Mammalian Analytical Development | Abzena

Analytical Development

  • Prequalified assays and Product Quality Attributes (PQA) assessment based on ICH guidance
  • Viral clearance validation

Abzena has analytical capabilities to support all stages of product and process development. Validated analytical methods are available to support release of early phase clinical material.

Assay Development/Qualification

Abzena’s standard platform assays and methods used for in-process testing and release of drug substance are qualified. The qualification examines a number of parameters based on applicable ICH guidance to show assay specificity, linearity and variability. Assays available at Abzena include:

  • pH – potentiometric
  • Identification – Isoelectric focusing, SDS-PAGE, Western blotting
  • Purity – SDS-PAGE, SEC-HPLC, RP-HPLC
  • HC Protein – ELISA
  • HC DNA – QPCR
  • Protein A – ELISA
  • Protein Content – A280/BCA Assay
  • Endotoxin – Kinetic Turbidimetic
  • Bioburden – Culture

Product Quality Attributes (PQA) Assessment

Product integrity

  • Confirmation of intact protein and subunit mass
  • Confirmation of subunit dissociation
  • Analysis for subunit loss and potential degradation
  • Confirmation of biosimilar concentrations
  • Product activity

Confirmation of binding characteristics

  • Confirmation of activity/functionality
  • Assessment of effector functions (ADCC/CDC) for antibodies
  • Product aggregation and purity

Analysis of product aggregation

  • Analysis of sample purity & confirm suitability of purification method
  • Product sequence confirmation and site specific modifications

Sequence coverage based on peptide mapping using LC-MS

  • Site specific modifications (deamidation, oxidation) using LC-MS
  • Product charged variants
  • Charged variants profiling using cation exchange chromatography

Viral Clearance Validation

Abzena can perform studies to provide a viral safety risk assessment.

shutterstock_143646112Working with Abzena

Abzena’s mammalian manufacturing services are tailored for each project to ensure that the objectives are met or exceeded. Experienced project teams are assigned to each study focusing on progressing projects through to results in the minimum amount of time. Our clients widely regard us as professional and attentive partners who deliver quality results.

To get more information, a quote or to schedule a teleconference please contact us.

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